Model Number 27MJ-501 |
Device Problems
Material Separation (1562); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020 a mechanical heart valve was selected for a procedure.The flap of the heart valve vibrated and the shaft piece fell off and the valve was not used.The procedure was successfully completed by using a different valve.The patient remained stable through out and post procedure.A clinically significant delay was reported, but there was no patient consequences or intervention due to this delay.
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Manufacturer Narrative
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Correction: manufacturer report 2648612-2020-00092, should not have been reported as a medical device report (mdr).Additional information indicated that there was no clinically significant delay and the event did not lead or cause serious injury or death.As such, the event is not reportable.
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Event Description
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On aug 12, 2020 a mechanical heart valve was selected for a procedure.The flap of the heart valve vibrated and the shaft piece fell off and the valve was not used.The procedure was successfully completed by using a different valve.The patient remained stable through out and post procedure.A clinically significant delay was reported, but there was no patient consequences or intervention due to this delay.
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Search Alerts/Recalls
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